Transcript Uscom BP+ Sales Presentation

DRAFT ONLY
Uscom BP+
Premium central blood pressure
and pulse pressure wave analysis
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The Measure of Life
DRAFT ONLY
USCOM BP+
• BP+ is a clinical and research device for rapid and accurate
measures of central aortic blood pressure
• Improves identification of hypertension and prediction of outcomes.
• As easy to use as current cuff based BP measurement devices.
• Calculates in around 60 seconds and requires no additional operator
training.
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The Measure of Life
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KEY BENEFITS
• Ultrafast SupraSystolic measure on inflate BP measurement
• In contrast to multiple inflate/deflate cycles required by other
products
• Speed is valuable for clinicians
• Children struggle to sit still during tonometry
• Significantly more clinically relevant information in the same
or less time than regular BP
• Simple one button automatic operation
• Familiar to clinicians and patients
• Avoids operator dependence
• Minimal user training
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The Measure of Life
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BP+ KEY MEASUREMENTS
• Central Blood Pressure
Systolic and Diastolic
• Brachial Blood Pressure
Systolic and Diastolic
• SupraSystolic rhythm strip
Easy identification of arrhythmias
• Pulse Rate
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CENTRAL BLOOD PRESSURE
• Central Blood Pressure (cBP)
• How is it different from
brachial?
• Outcomes
• cBP and brachial BP change
independently
• cBP responds differently to
Antihypertensive medication
• The individual response to
treatment is different
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CENTRAL BLOOD PRESSURE
“We have known for over half a century that brachial pressure is a poor
surrogate for aortic pressure, which is invariably lower than
corresponding brachial values. Recent evidence suggests that central
pressure is also more strongly related to future cardiovascular events
than brachial pressure, and responds differently to certain drugs.”
“We may be treating some subjects with relatively low central
pressures, and not treating individuals with elevated central pressures,
because they have brachial systolic pressures under current treatment
thresholds.”
Carmel M. McEniery, John R. Cockcroft, Mary J. Roman, Stanley S. Franklin, and Ian B. Wilkinson CENTRAL BLOOD PRESSURE: CURRENT
EVIDENCE AND CLINICAL IMPORTANCE. European Heart Journal (2014) 35, 1719–1725.
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CENTRAL BLOOD PRESSURE
What is cBP?
•
The blood pressure in the aorta near the heart.
How is cBP different from peripheral BP?
•
•
BP increases as it gets further from the heart due to the increasing
peripheral resistance of the small arteries.
The degree to which the peripheral BP is higher than cBP is not linear nor
predictable due partly to the varying compliance of the arteries.
Amplification of the pressure waveform moving from the aorta to the radial artery.
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CENTRAL PULSE PRESSURE WAVE
• The sum of the forward pressure wave, created by ventricular
contraction, and of the reflected pressure wave, produce the peak
systolic blood pressure in the aorta.
• Time to Reflection is when the
reflected pressure wave starts to
arrive
• Forward central pressure is
augmented by the reflected
pressure
• Central Augmentation index is ratio
of central Augmentation Pressure
over central Pulse Pressure*
* cAIx = AP/cPP (for people under 50 years of age)
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CENTRAL BLOOD PRESSURE
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VALIDATION
Uscom BP+ cBP validated as equivalent to invasive cBP
Invasive cBP
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VALIDATION
Invasive validation
•
Aaron C.W. Lin, Andrew Lowe, Karishma Sidhu, Wil Harrison, Peter
Ruygrok, and Ralph Stewart. Evaluation of a novel sphygmomanometer,
which estimates central aortic blood pressure from analysis of
brachial artery suprasystolic pressure waves. J Hypertens. 2012
Sep;30(9):1743-50. doi: 10.1097/HJH.0b013e3283567b94.
http://www.ncbi.nlm.nih.gov/pubmed/22796711
Noninvasive validation to tonometry
•
Rachel E.D. Climie, Martin G. Schultz, Sonja B. Nikolic, Kiran D.K. Ahuja,
James W. Fell and James E. Sharman. Validity and Reliability of Central
Blood Pressure Estimated by Upper Arm Oscillometric Cuff Pressure.
Am J Hypertens. 2012 Apr;25(4):414-20. doi: 10.1038/ajh.2011.238. Epub
2012 Jan 5. http://www.ncbi.nlm.nih.gov/pubmed/22223041
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REPRODUCIBILITY
As reproducible and repeatable as NIBP
1
0.9
ICC
0.8
0.7
0.6
0.5
(1)
(2)
Unpublished data, Otago University
Climie et al. P6.05, N=47
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The Measure of Life
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USCOM BP+
• BP+ is the most clinically applicable cBP monitor!
McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson AB. Central blood pressure:
current evidence and clinical importance. European Heart Journal (2014) 35, 1719–1725.
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SUPRASYSTOLIC BEAT
mmHg
RWR - Reflection Wave Ratio (AI)=(Pda/Pba)*100%
0.6
TR
0.5
b
- Time to Reflection = td -ta
RWTT - Reflected Wave Transit Time = tc - ta
SEP
0.4
- Systolic Ejection Period = te - ta
dP/dt - Pressure gradient
0.3
c
0.2
Pba
d
e
0.1
a
Pda
RWTT= tc - ta
SEP= te - ta
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50
100
150
time (ms)
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SUPRASYSTOLIC RHYTHM STRIP
PRV - Pulse Rate Variability measures variation in beat duration
dPP – Pulse Pressure Variation measures % variation in beat amplitude
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MEASUREMENT QUALITY
SNR – Signal to Noise Ratio provides qualitative assessment
Rhythm strip is visual confirmation of measurement quality
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KEY BENEFITS
• Accurate CBP with Clinical Validation to true Gold Standard of
Invasive catheter
• Comfortable Cuff
• Supersedes existing BP devices
• Sensitive to currently sub-clinical changes
• Its disruptive technology (not me too BP!)
• Standalone measurements and results display – NO PC!
• Internal Measurement Storage and Data Export Facilities
• Software for Reporting
• Connectivity to Digital Health Records
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SUPRASYSTOLIC TECHNOLOGY
Artery occluded due
to SupraSystolic cuff
Forward Wave
4
Reflected
Waves
1
Pressure is
generated by
the heart in
the aorta
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Reflected waves travel
back towards the aorta.
2
3
Pressure waves
travel to the end of BP+ measures
the artery and
cuff pressure
transferred to the
cuff and some
pressure reflected
The Measure of Life
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SUPRASYSTOLIC TECHNOLOGY
• The heart generates a pressure pulse that propagates through
aorta into the vascular tree.
• The pressure pulse enters subclavian-brachial artery where it
is reflected when it reaches the point where the cuff occludes
the artery.
• The pressure pulse travels back towards the aorta and is
reflected back down the subclavian and brachial arteries.
• This latter reflection is due to the impedance mismatch
between the relatively narrow subclavian and large diameter
aorta.
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SUPRASYSTOLIC TECHNOLOGY
• BP+ holds the cuff 30mmg above the measured systolic
pressure
• The Supra Systolic pressure wave recorded from the cuff is
the sum of these forward and reflected waves.
• BP+ uses a direct physiology based algorithm to model the
pressure wave transmission.
• Pulse pressure wave analysis determines central systolic,
diastolic BP and other parameters in typically less than 60
seconds!
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SUPRASYSTOLIC BENEFITS
• Full occlusion of flow in the brachial artery has several
advantages:
• Cuff is a deterministic termination impedance which
simplifies the model.
• No pooling of the blood below the cuff as would occur at
sub systolic pressures.
This pooling is more uncomfortable than the brief
SupraSystolic pressure (+/-12 seconds).
• Removes impact of peripheral vasculature state beyond the
cuff (hot/cold, bifurcations, etc.)
Improves energy transfer and signal quality
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SUPRASYSTOLIC BENEFITS
• Eliminated noise and artefact in the pressure wave due to:
• Reflections of peripheral bifurcations (radial/ulnar etc.)
• Individual variance from compressible tissue between cuff and
artery (thin, fat, muscular, etc. arms)
• Non-laminar blood flow from induced turbulence by artery walls
• Resulting in:
• The most physiologic and superior quality entire central pulse
pressure waveform
• Excellent accuracy and reproducibility
• BP+ stores all the recorded measurement data in each
measurement file.
Ensuring retrospective calculation of new parameters from
previously performed measurements
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The Measure of Life
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SUPRASYSTOLIC BENEFITS
• RWR reported value is directly off the measured pulse
pressure waveform (SupraSystolic) from the cuff, not from a
derived waveform.
• RWR is calculated from the average SupraSystolic pulse
displayed on the screen of BP+.
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The Measure of Life
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SUPRASYSTOLIC BENEFITS
• Supra Systolic capture of CBP vs the IEM approach of
sub diastolic etc (Richard!)
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The Measure of Life
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BRACHIAL vs TONOMETRY
• BP+ has been used on children as it’s quick and simple.
Children struggle to sit still for long enough to do accurate
tonometry.
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BRACHIAL vs TONOMETRY
“Bra-Rad-SBPAmp results in underestimation of central SBP using
brachial-BP-calibrated radial tonometry.”
RED Climie, DS Picone, MA Keske and JE Sharman.
Brachial-to-radial systolic blood pressure amplification
in patients with type 2 diabetes mellitus. Journal of
Human Hypertension (2015), 1–6
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COMPETITION
Uscom BP+
TensioMed
BPLab
AtCor
IEM
Australia
Hungary
Russia
Australia
Germany
USD 2,950
USD 6,000
USD 7,000
USD 13,000
USD 7,000
60 seconds
2 min
2 min
1 min
2 min
Stand-alone
ABP, needs
computer
ABP, needs
computer
Needs computer
ABP, needs
computer
CE, FDA, TGA
CE
CE
CE, FDA
CE, FDA
Aortic waveform
Central systolic
BP
Rough waveform
Rough waveform
Rough waveform
Physical model
Statistical
regression
Transfer function
Transfer function
Transfer function
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DISTRIBUTOR WEBSITE
• Sales, training, marketing and support material.
• White papers and peer-reviewed articles.
• Latest news
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WHAT THE RESEARCH SAYS
•
•
•
•
•
•
•
•
Individual response
Better predictor
Relates better to disease
Better measure of treatment
cBP and BP respond differently to medication
Less medication needed
Central BP goal differs from upper arm BP goal
Useful in pediatrics
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INDIVIDUAL RESPONSE
• Most classes of antihypertensive agents used as
monotherapy lower BP by a similar average amount.
However, the individual response to each agent is
unpredictable.
• Targets may be difficult to achieve or may not be tolerated in
some patients.
Heart Foundation Guide to management of hypertension 2008. Updated December 2010
http://www.heartfoundation.org.au/SiteCollectionDocuments/HypertensionGuidelines2008to2010Update.pdf
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cBP A BETTER PREDICTOR
• “Central arterial pressure is a better predictor of adverse
cardiovascular outcomes than brachial blood pressure”
Evaluation of a novel sphygmomanometer, which estimates central aortic blood pressure from analysis of brachial artery
suprasystolic pressure waves Aaron C.W. Lin, Andrew Lowe, Karishma Sidhu, Wil Harrison, Peter Ruygrok, and Ralph Stewart.
jhypertension.com DOI:10.1097/HJH.0b013e3283567b94
• “…central BP can differ greatly between individuals with
similar brachial BP.”
Patients with Type 2 diabetes mellitus have an exaggerated brachial and central blood pressure response to exercise: relation to left
ventricular hypertrophy. Sharman, J. E., Scott, J. A., Coombes, J. S., Prins, J. B., Leano, R. and Marwick, T. H. (2007). 28th Annual Scientific
Meeting of the High Blood Pressure Research Council of Australia 2006. (1476-1477). 6-8 December, 2006.
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cBP RELATES BETTER TO DISEASE
“central pulse pressure is more strongly related to vascular
hypertrophy, extent of atherosclerosis, and
cardiovascular events than is brachial blood pressure”
Artery Research 2009;3: 125-7 Hypertension 2007;50:197-203
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A BETTER MEASURE OF TREATMENT
• “The most important finding of the present study is that
central blood pressure responded differently to ergometer
and hand-grip exercises.”
• “central systolic blood pressure was increased after
isometric hand-grip, but not isotonic ergometer, exercise.”
Differential Response of Central Blood Pressure to Isometric and Isotonic Exercises Satoru Tanaka, Tomonori Sugiura, Sumiyo
Yamashita, Yasuaki Dohi, Genjiro Kimura & Nobuyuki Ohte SCIENTIFIC REPORTS | 4 : 5439 | DOI: 10.1038/srep05439
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cBP AND BP RESPOND DIFFERENTLY
TO MEDICATION
• “Moreover, anti-hypertensive drugs can exert differential
effects on brachial and central pressure.”
“Central blood pressure: current evidence and clinical importance
Carmel M. McEniery, John R. Cockcroft, Mary J. Roman, Stanley S. Franklin, and Ian B. Wilkinson
European Heart Journal (2014) 35, 1719–1725
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LESS MEDICATION NEEDED
“We conclude that guidance of hypertension management with cBP results
in a significantly different therapeutic pathway than conventional cuff BP,
with less use of medication to achieve BP control and no adverse effects
on left ventricular mass, aortic stiffness, or quality of life.”
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cBP GOAL DIFFERS FROM BP GOAL
Derivation and Validation of Diagnostic Thresholds
for Central Blood Pressure Measurements Based
on Long-Term Cardiovascular Risks
Hao-Min Cheng, MD, PhD∗; Shao-Yuan Chuang, PhD‖; Shih-Hsien Sung, MD‡; Wen-Chung
Yu, MD‡; Alan Pearson, AM, PhD∗; Edward G. Lakatta, MD∗∗; Wen-Harn Pan, PhD‖; ChenHuan Chen, MD†
J Am Coll Cardiol. 2013;62(19):1780-1787. doi:10.1016/j.jacc.2013.06.029
Hypertension | November 2013
NEW Central BP goals
Hypertension – cBP 130/90, Optimal – cBP 110/80
“cBP of 130/90 mmHg was determined to be the cut off limit for
normality……. This report represents an important step toward the
application of the CBP concept in clinical practice.”
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USE IN PEDIATRICS
Original Article
Validation of Oscillometric Pulse Wave Analysis
Measurements in Children
Jan 2014
Lee Stoner, Danielle M. Lambrick, Nicole Westrupp, Joanna Young, and James Faulkner. American
Journal of Hypertension 2014, doi:10.1093/ajh/hpt243
Oscillometric PWA provides valid measures of central
blood pressure in children aged 8–10 years.
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REGULATORY
• FDA clearance
• CE for Europe
• TGA for Australia
• Reimbursement in the USA
CPT code 93050, from 1 Jan 2016
• Brachial BP to ISO 81060-2:2014,
AAMI SP10, BHS Grade A
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The Measure of Life
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SUMMARY
• Central Blood Pressure
• cBP is different from brachial BP
• antihypertensive medication has a different effect on cBP
• Outcomes
• central pulse pressure is more strongly related to vascular disease
and cardiovascular events than is brachial
• Innovation
• Uscom BP+ uses SupraSystolic technology
• cBP with the most physiologic and entire pulse pressure wave
analysis
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CONCLUSION
In 60 seconds, Uscom BP+ provides:
•
•
•
•
•
•
Accurate SupraSystolic oscillometry
Non-invasive and operator independent
Affordable and standalone
Clinically significant, actionable measures
Easy to use
Familiar with no extra training
The premium Central Blood Pressure and Pulse
Pressure Wave Analysis device to improve diagnosis
and management of hypertension
Hypertension.
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Outcomes.
Innovation.
The Measure of Life